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Answers to some of the most common EPIDIOLEX® (cannabidiol) questions

If you have a question not addressed below, you can email medinfo-us@jazzpharma.com or visit our Contact Us page to request to be contacted by a Jazz Neurology Account Manager (NAM) or schedule a product presentation from a peer expert.

EPIDIOLEX and cannabinoids

  • EPIDIOLEX is the first and only FDA-approved prescription cannabidiol and the only cannabidiol formulation demonstrated in well-controlled clinical trials to be effective in reducing seizures associated with LGS, Dravet syndrome, and TSC
    • EPIDIOLEX was studied in over 900 patients with LGS, Dravet syndrome, and TSC—making up the largest controlled clinical trial program for an ASM in these conditions to date1*
    • EPIDIOLEX has a known and well-characterized safety profile
  • EPIDIOLEX manufacturing has been inspected by and is in accordance with FDA standards, resulting in highly controlled and consistent cannabidiol concentrations of 100 mg/mL, free from contaminants2
  • EPIDIOLEX is federally legal and eligible for insurance coverage for appropriate patients

*There was a second randomized controlled trial in 199 patients with Dravet syndrome that has been completed since its original approval.1

References: 1. Miller I, Scheffer IE, Gunning B, et al. JAMA Neurol. 2020;77(5):613-621. 2. Data on file. Jazz Pharmaceuticals, Inc.

  • EPIDIOLEX oral solution contains highly purified, plant-derived cannabidiol1
    • EPIDIOLEX is manufactured in accordance with FDA standards, resulting in highly controlled and consistent cannabidiol concentrations of 100 mg/mL1
  • Synthetic cannabinoids are produced in laboratories through a chemical reaction to structurally or functionally mimic the effects of endocannabinoids or phytocannabinoids2
  • There are no synthetic cannabinoid products that have been evaluated in Phase 3 controlled trials for the treatment of seizures associated with LGS, Dravet syndrome, or TSC

References: 1. Data on file. Jazz Pharmaceuticals, Inc. 2. Grotenhermen F. Cannabinoids. 2006;1(1):10-14.

  • Patients on other cannabinoid products were excluded from the EPIDIOLEX clinical trials1,2
  • Jazz Pharmaceuticals, Inc. cannot provide advice on converting from a cannabidiol/cannabinoid product to EPIDIOLEX

References: 1. Thiele EA, Marsh ED, French JA, et al. Lancet. 2018;391(10125):1085-1096. 2. Devinsky O, Patel AD, Cross JH, et al. N Engl J Med. 2018;378(20):1888-1897.

  • As stated in the Prescribing Information, patients taking EPIDIOLEX may test positive on urine cannabinoid screens. Patients/caregivers should inform the person conducting the drug test that the patient is taking EPIDIOLEX, an FDA-approved cannabidiol medicine prescribed by their physician
  • Please complete a Medical Information Request Form for additional information

EPIDIOLEX studies

  • In controlled and uncontrolled studies, including expanded access programs and other compassionate use programs, 1183 patients with LGS, Dravet syndrome, and TSC have been treated with EPIDIOLEX
    • 683 patients treated for more than 1 year
    • 155 patients treated for more than 2 years
  • EPIDIOLEX was also studied in open-label extension trials up to 3 years in LGS, Dravet syndrome, and TSC. The long-term safety profile of EPIDIOLEX in these open-label extension trials was generally similar to that observed in the pivotal trials for LGS, Dravet syndrome, and TSC1-3
    • In the open-label extension trials, titration to doses over the recommended maximum maintenance dose was permitted. At higher doses, an increase in adverse reactions was observed1-3
    • Eleven deaths were reported in patients with LGS; none were deemed to be treatment-related by the investigator1
    • Five deaths were reported in patients with Dravet syndrome, none of which were deemed related to treatment by the investigator2
    • There was 1 death reported during the TSC open-label extension, which was deemed unrelated to treatment by the investigator3

References: 1. Patel AD, Mazurkiewicz-Bełdzińska M, Chin RF, et al. Epilepsia. 2021;62(9):2228-2239. 2. Scheffer IE, Halford JJ, Miller I, et al. Epilepsia. 2021;62(10):2505-2517. 3. Thiele E, Bebin EM, Filloux F, et al. Presented at: 2022 American Epilepsy Society Annual Meeting; December 2022; Nashville, TN.

Dosing and administration

If necessary, EPIDIOLEX can be administered with certain nasogastric tubes (NG-tube) or gastrostomy tubes (G-tube). For specific instructions, please see the EPIDIOLEX Prescribing Information.

Yes. It may be used, but there are recommended dose adjustments.

Review dosing considerations for patients with hepatic impairment
  • As with most ASMs, EPIDIOLEX should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus
  • If withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered
  • Please complete a Medical Information Request Form for additional information
  • EPIDIOLEX is recognized by the Transportation Security Administration (TSA) as an FDA-approved cannabis-derived medicine, which means you can legally carry it on airplanes anywhere in the United States
  • For information about traveling with EPIDIOLEX, including rules and regulations, tips for navigating airport security, and useful contact numbers, patients can download a travel card
  • To help make sure EPIDIOLEX stays safe and secure when traveling, patients may order a free travel case
  • Since each country's laws vary, Jazz Pharmaceuticals is unable to provide guidance regarding travel with EPIDIOLEX to countries outside of the United States. Patients should contact the American consulate in their destination country and research the country's cannabis/marijuana laws prior to travel. In general, it is a good idea for the patient to carry proof of a valid prescription and to keep their medicine in its original container with the original label attached while traveling

Interactions, compatibility, allergies

  • Nearly half (49%) of the patients in the LGS clinical trials and 65% of patients in the Dravet syndrome clinical trial were taking concomitant clobazam
  • Valproate was the most commonly used concomitant ASM in the TSC Phase 3 trial, with 45% of patients receiving concomitant valproate, and 27% of patients receiving concomitant clobazam
  • Concomitant use of valproate and elevated transaminase levels at baseline increase the risk of EPIDIOLEX dose-related transaminase elevations
  • EPIDIOLEX can cause somnolence and sedation that generally occur early in treatment and may diminish over time; these effects occur more commonly in patients using clobazam and may be potentiated by other CNS depressants. Monitor patients for somnolence and sedation and advise patients not to drive or operate machinery until they have gained sufficient experience on EPIDIOLEX
  • Pneumonia was observed more frequently with concomitant use of EPIDIOLEX and clobazam
  • Elevated ammonia levels have been reported in some EPIDIOLEX-treated patients who also had transaminase elevations. Most cases reported concomitant use of valproate, clobazam, or both
  • Dose adjustment of EPIDIOLEX or concomitant medications may be required
Review dosing considerations for patients with hepatic impairment Review monitoring considerations for patients with hepatic impairment
  • EPIDIOLEX is made without sugar or carbohydrates, so it can be used with most epilepsy diets, such as the ketogenic diet
  • EPIDIOLEX should be taken consistently with respect to meals to reduce variability in cannabidiol plasma exposure
  • Caffeine: In vivo data showed EPIDIOLEX increases exposure to caffeine by 15% for Cmax and 95% for AUC compared to when caffeine was administered alone
  • Alcohol: Coadministration of EPIDIOLEX with alcohol increased exposure to cannabidiol, with 93% increased Cmax and 63% greater AUC
    • Concomitant use of EPIDIOLEX with other CNS depressants (including alcohol) may increase the risk of sedation and somnolence

Accessing EPIDIOLEX

  • EPIDIOLEX is dispensed by licensed pharmacists at the specialty pharmacies currently in the JazzCares® network
Find specialty pharmacies
  • Due to the weight-based dosing and titration for EPIDIOLEX, most patients will require a partial bottle fill, which the specialty pharmacy partners are equipped to handle
  • Trained staff at specialty pharmacies can assist with patient- and caregiver-specific questions throughout the patient journey on EPIDIOLEX
Complete a start form
  • Copay assistance is available for eligible commercially insured patients who reside in the United States
Review eligibility criteria

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